Comparison · NCT00679627-sae
Galantamine vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Galantamine vs Placebo: serious adverse events. Trial comparisons, record NCT00679627-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00679627-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.126 | 0.107 | 0.148 | wilson | |
| Risk in group 2 | 0.12 | 0.102 | 0.142 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00551 | -0.0231 | 0.0341 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.83 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.808 | 1.37 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Galantamine than on Placebo | 182 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Galantamine | During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability. | 129 | 1,024 | EG001 |
| Group 2 | Placebo | During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group. | 123 | 1,021 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Over 2 years
Source ClinicalTrials.gov
Trial
- Title
- A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease
- NCT number
- NCT00679627
- Phases
- PHASE3
- Conditions
- Alzheimer's Disease
- Interventions
- Galantamine, Placebo
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2013-09-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00679627?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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